Clinical Trial to Study Quality of Life in Prostate Cancer Patients by Randomizing Anti-androgen Versus Total Androgen Blockage Prior to Curative Intended Radiation Therapy

Karolinska University Hospital

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Bicalutamide

Study type: Interventional

Funder types: Other

Identifiers

NCT02382094

RCT-PC-QLS 2004

Details and patient eligibility

About

Phase III clinical trial to study quality of life in prostate cancer patients by randomizing anti-androgen versus total androgen blockage prior to curative intended radiation therapy.

Full description

Primary objective: To study the difference in quality of life in relation to anti-androgen versus total androgen blockage.

Exploratory parameters: ▪ Time to PSA relapse

• Time to symptom giving metastasis
• Overall survival

Patients with localized /locally advanced prostate cancer were subject to treatment with curative intention. They could be divided into three groups according to the risk of metastasis. Mainly intermediate risk group of patients were included in this study. Patients with low risk could be included if they were subject to neo-adjuvant hormonal therapy. Different risk groups were defined as below:

Low risk group: PSA ≤10 ng/ml Gleason score ≤ 6 Tumour stage ≤ T2b Intermediate risk group: Presence of 1-2 factors of high risk. High risk group: PSA >10 ng/ml Gleason score ≥7 Tumour stage T2c - T3b

Enrollment: 110 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Histopathologically verified prostatic adenocarcinoma.

2. All consecutive patients referred for radiation therapy with combination method i.e. both external beam RT and HDR brachytherapy or other fractionation with curative intention.

3. Patients with intermediate risk group of prostate cancer will mainly be included in this study where radiotherapy with intention to cure is indicated and possible to perform. The intermediate risk group is defined as having 1-2 high risk factors for metastasis. Patients with low risk can only be possible to include if there is an indication of neo-adjuvant hormonal therapy.

4. No signs of distant metastasis.

5. Informed consent.

Exclusion Criteria:

1. Failure to fulfill inclusion criteria.

2. Severe hepatic or renal failure, according to clinical and laboratory examinations, serum creatinine > 225 mmol/l.

3. Concomitant diseases that would influence the planned treatment (e.g. Inflammatory bowel disease, urinary incontinence, severe atherosclerosis, myocardial infarction within last 6 months.

4. Previous diagnosis of other malignant diseases excluding patients who are free from relapse after at least 5 years of diagnosis. Patients with basal cell carcinoma are includable.

5. Inability of the patient to cope with the study rules, due to abuses, mentalstatus or other reasons

6. Participation in other clinical studies at the same time if it considers may hamper the assessment of QoL.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Arm AA(anti-androgen)

Experimental group

Description:

Bicalutamide 150 mg per os daily + if needed Tamoxifen 10 mg against breast tenderness/gynecomasti.

Treatment:

Drug: Bicalutamide

Arm TAB (Total androgen blockade)

Other group

Description:

Bicalutamide 50 mg orally daily + Goserelin 3.6 mg subcutaneously every 28±2 days + if needed Tamoxifen 10 mg against breast tenderness/gynecomasti.

Treatment:

Drug: Bicalutamide